The invention concerns a surgical operation system, particularly an ophthalmologic surgical operation system for use during micro-surgical operations, particularly, ophthalmologic operation systems which utilize a supply unit providing at least one consumable, such as electric power, compressed air and/or a fluid, and multiple surgical instruments that are interchangeably connected to the supply unit using connecting tubes that carry the necessary consumables to the respective surgical instrument.
Over the past few years, the significance of micro-surgical operations in all surgical fields has increased considerably. A characteristic of such operations is the use of many different and various surgical instruments that often must be quickly interchanged.
An example is the removal of the natural optical lens of the eye because of clouding by cataract, and its replacement with an artificial intra-ocular lens. Ophthalmologic surgical operation systems (so-called phaco-machines) are used during such an operation. The phaco-machine includes a central supply unit with electrical power supply, a high-frequency generator, a tube and connecting system for surgical instruments, so-called head units, infusion bottles for rinsing fluid, and one or more pumps. If the head units are powered by compressed air, this is also provided.
Such a phaco-machine is known from the U.S. Pat. No. 5,249,121 wherein a central supply unit several head units is connected to. In this case, these include a piezo-electric-driven ultra-sound phaco-emulsification device, an aspiration and irrigation device, and a small light tube.
An ophthalmologic aspiration and irrigation system is known from European Patent No. 0 596 314 with which intra-ocular pressure during an operation may be held stable by introducing optionally a gaseous or fluid medium. The system includes a pressure unit, an aspiration unit, and an irrigation unit in the form of interchangeable inserts into a housing, which are connected together via external lines.
Head units are inserted into the interior of the eye through a small slit in the cornea. These head units are then used to penetrate the encapsulating sac containing the natural lens. Thereafter, the natural lens is shattered by ultra-sound from a phaco-emulsification device, the so-called phaco-head unit, and the fragments are vacuumed out using an aspiration and irrigation device and rinsing fluid. Other head units used include bi-polar high-frequency coagulators (to prevent hemorrhaging, or penetration of the encapsulating sac by the lens shards). The operator observes the operation area using an ophthalmologic stereomicroscope. He usually controls the head unit function by means of a foot switch.
When another head unit is required in the course of an operation, e.g., an aspiration and irrigation device instead of a phaco-head unit, the head unit formerly used must be disconnected from the supply tube and line connecting it to the phaco-machine, and the new head unit must be connected. Additionally, the supply unit must be re-adjusted in order to ensure proper supply to the new head unit. An adjustment unit such as a keypad, rotating switch or similar device is provided for this purpose so that the supply parameters may be adjusted for each operating device. Thus, for example, only one electrical connection is required for an electro-cauterizer, and no connection is required to an aspiration and irrigation device (thus, no fluid connections); such fluid connections are required, however, for the phaco-head unit and for a vitrectomy head unit.
Since such internal eye operations must be performed as quickly as possible in order to prevent unnecessary irritation to the patient and other side effects, the operator must have optimal support during the operation, particularly during exchange of head units so that the necessary new parameters for a head unit may be quickly and reliably set when the head unit is connected. This has usually been performed either by the operator himself or by a nurse participating in the operation and monitoring the proper function and manipulation of the phaco-machine. Therefore, optimal cooperation of the operating team is a requirement for rapid and successful machine operation.
A problem with existing phaco-machines is sterility and sterilization of the entire surgical operation system. If, for example, a head unit must be replaced because of improper sterilization, then the replacement of tubes with sterile ones, the filling of the tubes, the routing of the tubes through specified guides in the machine, and the establishment of connections between the pump and the pressure sensors (depending on the type of phaco-machine) can require from five to ten minutes for conventional phaco-machines. If it is necessary to re-configure the phaco-machine during the operation on a patient, this interval can be very long not only for the patient, but also for the operating team. Even sterilization of phaco-machine parts requires time. If, for example, a head unit must be sterilized, the head unit with its connecting tubes and lines must be disconnected from the phaco-machine and then sterilized in the sterilizer. Then a sterile head unit with its connecting tubes and lines must be connected to the phaco-machine, and the tubes must be filled with rinsing fluid. This reconfiguration is complicated and time-consuming.
Even the exchange between various head units is complicated for conventional phaco-machines. For this, both the hose and electrical connections of the used head unit must be disconnected and reconnected to the new head unit. Then the machine must be re-adjusted using the control unit so that the supply unit is informed regarding the necessary supply parameters for the new head unit. Only then can the operation continue with the new head unit. Repeated exchanges between various head units are very time-consuming and inconvenient with conventional systems, and can also cause additional risks if a new head unit is urgently needed, or when readjustment to the phaco-machine is required.
The principal objective of the present invention is to provide a conventional surgical operating system, particularly an ophthalmologic surgical operating system, so that any head unit required by the operator is quickly available to him, and such that re-adjustment of any necessary surgical operating system parameters is performed reliably. Additionally, reliable data should be displayed to the user that informs him/her regarding the functional condition of the operating system. It should particularly ensure that all units are in the condition and status required for the operation.
This object, as well as other objects which will become apparent from the discussion that follows, are achieved, according to the present invention, by providing a surgical operation system wherein the supply unit includes several connection interfaces, one for each surgical instrument; each surgical instrument is stored in its own sterilizer unit that is connectable to a connection interface; each sterilizer unit includes an identifying coded connector for the surgical instrument that fits into a querying connector of the supply unit when the sterilizer unit is connected to the supply unit; and a control unit is connected to all the connection interfaces using the querying connectors, it identifies the connected surgical instrument for each connection interface and it sets the parameters for its supply of consumables
Accordingly, the surgical operating system, e.g., the above-mentioned phaco-machine, includes a supply unit with several connection interfaces for each surgical instrument. Using this system, each surgical instrument is stored in a sterilizing unit which can be docked on the supply unit. Each sterilizing unit contains the head unit connection tubes and a roll-up mechanism for the head unit connection tubes. Further, it includes a coded identifying xe2x80x9cqueryingxe2x80x9d connector for the included head unit that connects to a corresponding mating connection on the supply unit when the sterilization unit is docked. This querying connector is connected with the control unit that supervises the function of the surgical operating system and that identifies the head unit connected to that connection interface. It also automatically adjusts the operating system parameters for the function of that particular head unit.
Preferably the supply unit is separated into a basic unit and a distributor unit provided with connection interfaces for the sterilizing units and connectable to the basic unit. This distributor system contains a tube system to supply the head unit with fluid and, when necessary, compressed air. This design of a surgical operating system is applicable and advantageous in many fields of surgery, and particularly in micro-surgery, particularly for such operations in which several surgical instruments must be interchanged. The following will refer to an ophthalmologic surgical operating system, a so-called phaco-machine, without prejudice to other potential uses.
Using the surgical operating system as described by the invention, it is possible to operate quickly and cleanly and most importantly under sterile conditions. When a head unit is removed from the sterilizer, the attached connecting tubes and any necessary electrical connections are also removed. When a head unit is returned into the sterilizer, the connections are automatically rolled up by the roll-up mechanism, so that the connecting tubes no longer lie around on an instrument tray and become entangled with one another.
With use of such a surgical operating system, the operation is considerably easier for the whole operating team. Thus, to change to a new head unit, the operator needs only to place the current head unit into its sterilizer (connections are automatically rolled up) and then take the next head unit from its own sterilizer in order to continue the operation. The control unit is automatically informed via activation sensors in the sterilizers when a head unit is replaced into its sterilizer and when the new head unit is removed from its sterilizer as to which head unit is current, and it then automatically adjusts system parameters for the new head unit. Exchange between various head units is thus possible without complications. Inconvenient exchange of head units (as is the case with conventional surgical operating systems such as the above-mentioned phaco-machine) is no longer necessary.
Automatic recognition of the latest head unit attached by means of coded connectors further excludes the risk that the head unit is exchanged but the operator forgets to re-adjust the operating system.
Overall, the operator enjoys extensive freedom in selection of available head units without suffering the risk of an improper system adjustment.
Thus, one has the option with a phaco-machine, for example, to dock two phaco-head units with different phaco-needles in separate sterilizers. The operator can thereby compare the effectiveness of different phaco-needles on one patient and select the most favorable one. It is also sometimes worthwhile to use two different phaco-needles or head units for two different purposes during one operation. Such options practically do not exist with conventional phaco-machines, since reconfiguration with another head unit as described above is possible only with significant loss of time, and such a method is normally not used.
A significant advantage of the invention with respect to conventional surgical operating systems is that the individual sterilizer units, or the sterilizer and the distributor unit, can easily be removed from the basic unit for purposes of cleaning, sterilization, or repair. Then another sterilizer or another distributor unit is docked with the basic unit. Work with the operating system may be continued without interruption. The operating system xe2x80x9cdown timexe2x80x9d required with conventional systems for cleaning, sterilization, or repair is thus considerably reduced. Rapid interchangeability of a head unit with its supply lines in its own sterilizer also reduces the former risk of working with equipment that is not properly sterilized.
In order to clean the removed sterilizer or distributor unit, it is advantageous to provide a separate rinsing station to which the sterilizer or distributor unit may be docked according to the same principle, i.e., so that the rinsing station includes connection interfaces for distributor units and for sterilizers. As soon as a sterilizer or distributor unit is connected to the rinsing station, the tube system from the sterilizer or distributor unit is cleansed with rinsing fluid. The rinsing station can be designed as an xe2x80x9cintelligentxe2x80x9d station, in other words a control unit that automatically performs the cleaning steps. This rinsing station may be connected with the surgical operating system control unit via a data link so that the control unit receives the identification data and the cleansing status of the cleansed unit. Such a communication to the phaco-machine control unit can also be accomplished after sterilization. The data can also be manually provided to the control unit. It is also possible for the sterilizer and distributor units to include an electronic data buffer in which the procedures and processes performed on the unit are stored. Upon docking of the unit with the surgical operating system, the data are delivered to the control unit, and accepted as necessary,. In this manner, the control unit recognizes whether the docked unit has been properly prepared for use. If, for example, a non-sterilized unit is connected by mistake, then the control unit may issue an alarm and corresponding display.
The operating system may also include a counter mechanism by means of which the quantity of usages of a part of the surgical operating system may be determined. This counter mechanism would preferably be coupled with a timer mechanism that measures the usage time of the component monitored by the counter mechanism.
Preferably individual surgical instruments, individual sterilizers, and the distributor units are equipped with the counter and/or timer mechanism. Of course, the supply unit can also be equipped with such monitoring equipment.
Equipping the supply unit with such monitoring equipment specifically allows for the monitoring of the individual components, and allows for the issuance of a warning signal or limitation (or even shutdown) of a function in case usage limits established from experience are exceeded. This can thereby alert the user to maintain service intervals, for example.
The counter and/or timer mechanism used to monitor the sterilizer and surgical instruments or head units would preferably be mounted in the sterilizer so that the quantity of sterilizer and head unit usages can be registered. For the case of an ophthalmologic surgical operating system, the counter and/or timer mechanism could be so adjusted that, for example, after 50 usages of the surgical instrument (such as a phaco-head unit), the phaco-needle should be changed and the surgical instrument connecting tubes should be checked for integrity. After 100 cycles of the phaco-head unit in the sterilizer, an alert might be issued that the sterilizer and phaco-head unit should be returned to the manufacturer for service. If this does not occur, then, as mentioned above, function of the phaco-head unit can be blocked. In this manner, the user would to some extent be forced to perform (or have performed) prescribed servicing such as tube replacement, measurement of the head unit, and safety checks.
A counter mechanism also allows the number of cleanings, sterilization procedures, and servicings to be counted, and to be passed to the control unit. This can occur both for the sterilizer and for the distributor unit. Total counts from the counter and/or timer mechanism can be displayed at any time so that the user can have a visual image of the entire surgical operating systems readiness status.
A counter mechanism that records the number of cleanings, sterilizations, and servicings, etc., can be a simple mechanical or electronic unit that advances its count every time the sterilizer or distributor unit is docked to a servicing station. The quantity of counts can be displayed either on the sterilizer itself, the distribution unit or on a separate display via the control unit.
The counter mechanism can help ensure that, for example, the surgical instrument has been rinsed or sterilized properly after each use. This can be achieved via a corresponding display on the control unit. A function shut-down of the surgical operating component being monitored is also possible, and the shut-down would only be lifted when the component has been properly prepared for use, i.e., cleansed, rinsed, or sterilized.
Preferably, sterilizer sensors (such as small temperature sensors that determine whether the proper sterilizing temperature is achieved during a sterilization procedure) can be linked with the surgical operating components that must be sterilized at certain intervals. Preferably component function is restored by the control unit only after this is achieved.
Based on this invention the surgical operating system can be designed in modules so that the width of the sterilizer determines the width of the module. This modular design allows practically-any surgical operating system configuration so that it is possible to adapt the operating system to future developments. Thus, a new module can be connected to an existing basic unit that is suitable for connection to a newly-developed head unit with its sterilizer.
For a full understanding of the present invention, reference should now be made to the following detailed description of the preferred embodiments of the invention as illustrated in the accompanying drawings.